Compliance Code and Regulations for PLM [Cheat Sheet]

Regulations impacting product lifecycle management (PLM) vary by region and industry. Below are the most common product lifecycle industry/government requirements and guidelines:

ISO 9001

Requirements for quality management systems and ensuring products meet regulatory requirements.

ISO 14001

Guidelines for environmental management systems that aim to reduce environmental impacts throughout the product lifecycle.

ISO 31000

Risk management principles and guidelines for throughout the product lifecycle.

ISO 13485

Quality management system requirements specific to the design and manufacture of medical device products.

ISO 27001 / IEC 27001

Standards for information security management for sensitive company info throughout the product lifecycle.

AS9100

Quality management requirements specific to the design and manufacture of aerospace industry products.

21 CFR Part 820

US FDA regulations regarding lifecycle management for pharmaceuticals and medical devices.

REACH (Registration, Evaluation, Authorization, Restriction of Chemicals)

EU regulations regarding chemical substances to protect human health and the environment.

ROHS (Restriction of Hazard Substances)

Restricting the use of specific hazardous materials found in electrical and electronic products.

GDPR (General Data Protection Regulation)

EU data protection and privacy rules apply to PLM systems that handle personal data.

ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations)

US regulations for the import and export of defense-related and dual-use items.

SAE Standards

Society of Automotive Engineers standards for PLM in the automotive and aerospace industries.

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